QUALITY ASSURANCE MANUAL · 2015. 5. 15. · 4.06 Logbooks ... 4.07 Procurement Control .....25 4.08 Commercial Dedication ... This Quality Assurance System Manual covers only those

ASSURANCE TECHNICAL SERVICES INC 400 PARK AVENUE DELAWARE OH 43015

ATS QAS-NQA1 Rev 3 12 May 2015 Page 1 of 43

© 1989 – 2015 ATS Inc. All Rights Reserved

Uncontrolled unless stamped in red ink on cover page.

Level I

Definite Scope

QUALITY ASSURANCE SYSTEM MANUAL

For Nuclear Safety Related Test Programs Performed by, or Under the Management of,

Assurance Technical Services, Inc.

This Document is controlled only if stamped above, with copy number and assignee’s name, by the ATS Quality Organization.

APPROVALS

Approved by:

12 May 2015

Andrew P. Clark PE, ATS President Date

Approved by:

12 May 2015

J. Edward Thomas, ATS Q. A. Manager Date





REVISIONS

Rev Date Description

0 23 Mar 2011

Original revision. This document was extracted from ATS QAS 89-001 Rev 4 and edited as necessary.

Approvals: A. P. Clark PE (ATS President) J. W. Eblin (ATS QA Manager)

1 27 Jun 2013

Chapter 0: Changed title of this section. Added the approval of the Level 1 manual in ¶2.

§3.04: Added Management Review to QA Manager’s Responsibilities.

§4.07.03: QA Manager verifies purchasing requirements are met.

§4.07.04: Removed exemption.

§4.07.05: Reworded exemption 05 and renumbered as 04.

§4.07.06: Rewritten to clarify usage of unaudited calibration suppliers as being an application of Commercial Grade Dedication.

§4.08.00: Added clarification language to Commercial Dedication.

§4.11.00: Added clarification language to Process Control.

§4.16.00: Added clarification language to Nonconforming Product.

§4.29.00: Added clarification language to Deviations.

Approvals: Andrew P. Clark PE (ATS President) J. Edward Thomas (ATS QA Manager)

2 06 Feb 2014

§1.03.00: Added subsection.

§1.04: Expanded discussion of Quality System documentation.

§3.02 & 3.07: Clarified role of Responsible Engineers.

§4.07.06: Expanded to address Commercial Grade Surveys.

§4.08: Expanded to clarify processes used and relation to EPRI NP-5652.

§4.13.03: Added subsection.

§4.16.00: Clarified distinction between Nonconformances, Anomalies, and Deviations.

§4.17: Modified to conform to SOP 4.17-01 Rev 2.

§4.30.00: Clarified validation of data acquisition software.






3 12 May 2015

§1.03.00: Clarified quality system objective.

§1.04: Added Table 1.01.

§3.00: Added Purpose to Organizational Structure.

§3.02: Added Customer Cognizant Engineer to Organization Chart.

§3.04: Clarified autonomy and duties of Quality Assurance Manager.

§3.09: Clarified employee duties.

§3.10: Added description of Customer Cognizant Engineer.

§4.09.05: Expanded to reflect current practice.

§4.19.04: Addressed digital backups of quality records.

§4.21.02: Changed “Customer” to “organization” in ¶3.

§4.27: Expanded to reflect current practice.

Throughout: Edited grammatical tense for consistency.


A bar in the right margin marks text containing significant changes implemented in the most recent revision of this document





CONTENTS

0 Scope and Authority .........................................................................................7

1 Introduction ......................................................................................................9

1.01 Purpose ......................................................................................................9

1.02 Background ................................................................................................9

1.03 Provenance .............................................................................................. 10

1.04 Organization of ATS Quality System Documentation ............................... 11

1.05 Organization and Use of this Manual ........................................................ 11

2 Quality Policy ................................................................................................. 15

3 Organizational Structure ................................................................................ 16

3.00 Scope ....................................................................................................... 16

3.01 Legal Structure ......................................................................................... 16

3.02 Internal Organization ................................................................................ 16

3.03 President .................................................................................................. 17

3.04 Quality Assurance Manager ..................................................................... 18

3.05 Lead Auditors ........................................................................................... 18

3.06 Project Technical Managers ..................................................................... 19

3.07 Responsible Engineers ............................................................................. 19

3.08 Project Quality Managers ......................................................................... 20

3.09 All ATS Personnel .................................................................................... 20

3.10 Customer Cognizant Engineers ................................................................ 20

4 Quality System Elements ............................................................................... 20

4.01 Contract Review ....................................................................................... 22

4.02 Project Quality Planning ........................................................................... 23

4.03 Design Control .......................................................................................... 23

4.04 Design Documents ................................................................................... 23

4.05 Controlled Documents .............................................................................. 23

4.06 Logbooks .................................................................................................. 24

4.07 Procurement Control ................................................................................ 25

4.08 Commercial Dedication ............................................................................ 27

4.09 Control of Customer Supplied Product ..................................................... 27

4.10 Inventory Control ..................................................................................... 29

4.11 Process Control ........................................................................................ 29





CONTENTS

4.12 Inspection Control ..................................................................................... 30

4.13 Test Control .............................................................................................. 30

4.14 Metrology .................................................................................................. 30

4.15 Identification of Product Status ................................................................. 32

4.16 Control of Nonconforming Product ........................................................... 32

4.17 Corrective and Preventive Action ............................................................. 32

4.18 Handling, Storage, and Shipping .............................................................. 34

4.19 Quality Assurance Records ...................................................................... 34

4.20 Internal Audits ........................................................................................... 35

4.21 External Audits ......................................................................................... 35

4.22 Supplier Audits ......................................................................................... 36

4.23 Personnel Qualifications ........................................................................... 37

4.24 Servicing ................................................................................................... 37

4.25 Statistical Techniques ............................................................................... 38

4.26 Hold and Notification Points...................................................................... 38

4.27 Intellectual Property Protection ................................................................. 39

4.28 Reporting of Defects and Noncompliance ................................................ 39

4.29 Deviations ................................................................................................. 41

4.30 Software Control ....................................................................................... 41

5 References .................................................................................................... 43





TABLES AND FIGURES

Table 0.01 Cross Reference from Applicable US Regulations ..................................8

Table 1.01 Standard Operating Procedures under this Manual ............................... 12

Figure 3.01 Organization Chart ................................................................................. 16





0 SCOPE AND AUTHORITY

This Quality Assurance System Manual covers only those elements of ATS’ (Assurance Technical Services) comprehensive system that must apply to orders for testing of nuclear safety related equipment.

The initial issue and all revisions of this Quality Manual are prepared by the Quality Assurance Manager and approved by the President. Revision status is indicated in the title block (in the header) and in the Revisions table beginning on page 2.

The regulations given in 10CFR21 and 10CFR50 Appendix B apply statutorily to nuclear safety related equipment intended to be used in the United States. As a matter of ATS policy, the requirements and practices necessitated by these regulations are applied to nuclear safety related work regardless of the intended application country.

This Manual applies to work performed by ATS if either of the following conditions applies:

a. The terms of a written and accepted customer Purchase Order invoke this Manual, 10CFR50 Appendix B, 10CFR21, or NQA1-19941.

b. The President (§3.03) orders applicability based upon the nature of the subject project.

All projects subject to this Manual shall be designated as “Special” QA grade per the comprehensive system and thereby are easily distinguishable from other projects.

Table 0.01 lists the applicable sections of US regulations, including all 18 criteria specified in 10CFR50 Appendix B, with cross-references to the applicable chapters or sections of this Manual.

1 If a customer invokes a different edition of NQA1, or any of its supplements, ATS’s

compliance therewith will be addressed at contract review.





Table 0.01: Cross Reference from Applicable US Regulations

US Regulation QAS-NQA1 Chapter or Section

10CFR21................................................................................................................... §4.28

10CFR50 Appendix B Criteria:

I Organization ............................................................................................. Chap 3

II Quality Assurance Program ................................................ Chap 1, §3.02, §4.02

III Design Control ............................................................................................. §4.03

IV Procurement Document Control .................................................................. §4.07

V Instructions, Procedures, and Drawings .................................... §4.01, 4.02, 4.04

VI Document Control ........................................................................................ §4.05

VII Control of Purchased Material, Equipment, and Services ......... §4.07, 4.08, 4.10

VIII Identification and Control of Materials, Parts, and Components ......... §4.09, 4.10

IX Control of Special Processes ....................................................................... §4.11

X Inspection .................................................................................. §4.12, 4.25, 4.26

XI Test Control ................................................................................................. §4.13

XII Control of Measuring and Test Equipment .................................................. §4.14

XIII Handling, Storage, and Shipping ................................................................. §4.18

XIV Inspection, Test, and Operating Status .............................................. §4.06, 4.15

XV Nonconforming Materials, Parts, or Components ............................. §4.13, §4.16

XVI Corrective Action ......................................................................................... §4.17

XVII Quality Assurance Records ......................................................................... §4.19

XVIII Audits ........................................................................................ §4.20, 4.21, 4.22





1 INTRODUCTION

1.01 Purpose

There are three principal reasons for ATS to maintain a documented quality assurance program.

1. It promotes focus and discipline to be shared by all ATS personnel and suppliers.

2. The ATS Quality Assurance System Manual provides a framework for the application of planned and systematic actions necessary to provide adequate confidence that products provided by ATS will meet or exceed the requirements of our customers.

3. It is a statutory requirement in some instances (such as the testing of nuclear safety related equipment, the work-scope of this Manual).

1.02 Background

Beginning with ATS’ founding in 1986, the documented quality system applied only to nuclear qualification testing and was primarily focused on one customer. Although no documented quality system applied outside this scope, ATS management informally applied the same quality standards to all its work and products.

In 1998, ATS’ documented Quality Assurance System was expanded to encompass virtually all work performed by, or under the management of, ATS. The expanded quality system was responsive to the intent of ISO9001:1994 with extensions as required to continue ATS’ commitments to safety, quality, workmanship, and customer satisfaction.

In order to accommodate ATS’ wide range of customer and regulatory requirements, without burdening less demanding projects with unnecessary administrative overhead, the comprehensive system was designed around three quality grades. The ATS quality grades are as follows.

Exempt work is not subject to any documented quality assurance requirements. This includes projects performed where ATS is the end user and projects where the customer specifically waives application of formal quality procedures. Exempt grade project numbers are designated with the suffix “X”.

Basic work is subject to typical quality and documentation requirements of industrial or commercial work. Basic grade projects numbers are designated with the suffix “B”.

Special work is subject to more demanding quality and documentation requirements. This includes work subject to strict safety related requirements such as those specified in 10CFR50 Appendix B. All Special quality grade projects require preparation of a Project Quality Plan. This plan includes documentation of any quality requirements specific to that project that are not included in ATS’ documented quality system. Any such additional requirements are designated as Supplemental requirements. Special grade project numbers are designated with the suffix “S”.


ATS QAS-NQA1 Rev 3 12 May 2015

Page 10 of 43



The original revision of this Manual (ATS QAS-NQA1), published in 2011, was prepared in response to customer requests for a simple, top-level manual, focused on ATS’ compliance with the requirements of 10CFR21 and 10CFR50 Appendix B as they apply to testing of nuclear safety related equipment defined as Special Work in this Manual. Efforts have been made to keep the system presented herein both coherent as a stand-alone document and consistent with ATS’ long history of comprehensive quality management.

Within this Manual, ATS’ quality and documentation requirements are tailored to the applicable scope of work: testing of nuclear safety related equipment. Hence, the Special quality grade applies to crucial activities (e.g. metrology). Other activities that do not directly influence nuclear safety (e.g. design and construction of test fixtures) are treated according to the Basic or Exempt quality grade as applicable.

1.03 Provenance

ATS’ quality system is responsive to the following factors, listed in order of decreasing precedence.

1.03.00 Natural Law

Although its primacy is inevitable, it is nonetheless useful to formally recognize natural law (e.g. laws of motion, thermodynamics, etc.) as the foundation of ATS’ work and therefore its quality system. Unfortunately, it is often easy to overlook (or tempting to pretend to accommodate) requirements imposed by customers or regulators that contradict natural laws. However, any such deference would likely constitute engineering malpractice and inevitably lead to corruption of the quality system. (For example, customers sometimes impose concurrent environmental conditions, including temperature, pressure, humidity, and composition, that are physically impossible to achieve but can appear, to an inexpert observer, to actually occur.) Formal recognition of natural law’s preeminence prevents the absurd situation of being bound by rules to pretend to do the impossible (regardless of whether the customer believes it’s impossible).

Natural law also directly guides ATS’ implementation and maintenance of its quality system. Noteably, it is impossible2 to create a finite system of consistent and complete rules to control a non-trivial bureaucratic system. Management accounts for this principle by electing to strive for programmatic consistency at the expense of completeness. Therefore, ATS’ objective in its documented quality system is to codify the minimum set of consistent requirements that satisfy its lawful and ethical duty, while meeting its germane regulatory obligations and best serving the needs of its customers. Inevitable minor gaps in the quality system are addressed by management as encountered but do not, and must not, automatically trigger system changes to preclude recurrence. Otherwise, accretion of more detailed and less critical requirements will prove sclerotic, distracting from more important issues, stifling creativity & responsiveness, and displacing sound engineering & business judgment.

2 This principle is based on the Incompleteness Theorems published by Kurt Gödel in 1931.



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1.03.01 Engineering Law & Ethics

As a licensed engineering firm, ATS is subject to the statutory requirements of ORC 4733 as well as established engineering ethics including those listed in OAC 4733-35. Although these laws and rules do not address quality assurance per se, they do influence the structure of the quality assurance system in an engineering firm.

Furthermore, ATS management recognizes that many of the activities involved in nuclear safety related testing services, as provided by ATS, fall within the scope of the legal definition of engineering services subject to licensure law per ORC 4733.01(D). Hence, this Manual must address the organization and responsibility requirements of laws relating to the practice of engineering.

1.03.02 Nuclear Regulations

In order to provide nuclear safety related testing in the United States, ATS must comply with the quality assurance requirements of 10CFR50 Appendix B. Hence, the system presented in this Manual is substantially structured to address the applicable quality criteria of this regulation as shown in Table 0.01 on page 8.

Additionally, ATS must comply with the reporting requirements of 10CFR21. These requirements are addressed in §4.28.

1.03.03 ATS Quality Philosophy

ATS management is committed to the ideal that it is desirable and feasible to apply the ethic of craftsmanship, on an organizational level, within a framework of modern quality assurance.

1.03.04 Industry Standards

In order to streamline cooperation on quality related issues between ATS and other organizations, it is useful to conform to widely accepted standards. To this end, ATS management historically selected ISO-9001. Since 2011, ATS management has recognized that ISO/IEC 17025 is a preferred model quality standard, particularly in ATS’ areas of business, for those quality related issues beyond the scope of 10CFR50 Appendix B.

1.04 Organization of ATS Quality System Documentation

ATS’ Quality System is organized into multi-level documentation as follows:

Level 1 is system-wide policy manuals (e.g. this Manual) that address the approach, responsibilities, and general requirements under ATS’ Quality System.

Level 1 Quality Manual(s) are generally available for distribution to legitimate interested parties and are protected under US copyright law.

Level 2 includes Standard Operating Procedures (SOPs) that provide implementation details on an organization wide basis and draw their provenance directly from the applicable Level 1 Quality Manual. SOP’s are numbered according to the applicable section number in this Level 1 Manual and are listed in Table 1.01.



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Table 1.01: Standard Operating Procedures under this Manual (Revisions are current on the date of publication of this revision of this Manual)

SOP Title Rev Date

3.05-01 Qualification of Nuclear Lead Auditors 1 22 Aug 2011

4.01-01 Contract Review 2 07 Jun 2011

4.02-01 Special Grade Project Quality Planning 0 29 Apr 2011

4.05-01 Standard Operating Procedure Development 1 14 Apr 2011

4.05-02 Document Control 1 14 Apr 2011

4.06-01 Project Logbooks 0 21 Apr 2011

4.07-01 Special Grade Supplier Approval 4 07 Mar 2014

4.07-02 Special Grade Purchasing 2 05 Sep 2014

4.09-01 DUT Control 0 03 May 2011

4.12-01 DUT Inspections 0 27 Apr 2011

4.13-01 Special Grade Test Control 1 13 Dec 2013

4.13-02 Reporting of Anomalies 0 02 Dec 2013

4.14-01 Measurement Standards 1 05 Sep 2014

4.14-02 Calibration 1 05 Sep 2014

4.14-03 Measuring Instruments 1 05 Sep 2014

4.14-04 Measurements 0 13 May 2013

4.15-01 Special Grade Test Status Tracking 0 05 May 2011

4.17-01 Corrective & Preventive Action 2 06 Dec 2013

4.19-01 Quality Assurance Records 0 22 Apr 2011

4.20-01 Internal Audits 0 14 Apr 2011

4.21-01 Customer Audits 0 11 Apr 2011

4.22-01 Supplier Audits 0 12 Sep 2013

4.23-01 Personnel Training 1 29 Sep 2014

4.26-01 Hold & Notification Points 0 04 May 2011

4.28-01 Reporting of Defects and Non-Compliance 1 07 Jan 2014

4.29-01 Deviations 2 31 Dec 2013



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Also included under Level 2 is ATS’ glossary of quality related terms, ATS QAS-Glossary.

Level 2 Documents are approved by the President and the Quality Assurance Manager.

Level 2 Documents are protected under US trade secrecy law and are available to approved individuals while on ATS premises. Approved individuals may include ATS employees, quality auditors, and regulatory inspectors. At management’s discretion, these documents may be released outside of ATS when a valid non-disclosure agreement is in place.

Level 3 is any other quality documentation. This includes plans, procedures, drawings, and reports that apply only to particular projects, products, or devices.

Level 3 Documents comply with the requirements of the applicable Level 1 and Level 2 Documents and are approved by the applicable project management team (Project Technical Manager and Project Quality Manager per §3.06 & §3.08 herein) or their superiors.

Any contract deliverable Document that conveys ATS’ Engineering work product to a Customer must be approved by a Responsible Engineer (per §3.07 herein) who exercised supervisory authority during its development. This includes drawings, specifications, procedures, or reports that transmit engineering design results, engineering analysis results, or conclusions of engineering judgment. This does not include incidental or supporting records such as correspondence, commercial instruments, notifications, Calibration Records, Instrument Summaries, logs, or data sheets.

Level 3 Documents are protected under US trade secrecy law and are available to approved individuals while on ATS premises. Approved individuals may include ATS employees, quality auditors representing the applicable Customer(s), and regulatory inspectors. At management’s discretion, these documents may be released outside of ATS when a valid non-disclosure agreement is in place.

Documents that are contract deliverables are generally only released to the applicable Customer(s). Intellectual property rights in deliverable documents are jointly owned by ATS and the applicable Customer(s). Typically, the Customer is granted reasonable distribution rights consistent with their contracted end use.

In order to accommodate ongoing improvement of ATS’ Quality System, Level 1 and Level 2 Documents are revised from time to time. Although management endeavors to maintain consistency between these Documents, there will be instances where Documents are inconsistent until such time that errors are discovered or planned systemic changes are promulgated through all affected Documents.

When inconsistencies are found between different ATS Quality Documents, management must be notified (in case they are unaware). In any event, the Level 1 or Level 2 Document with the most recent revision date prevails. Refer to Table 1.01 on page 12 for a list of the current revisions of SOPs at the time of publishing this revision of this Manual. In the event of an inconsistency between this Manual and any of the SOP revisions listed in Table 1.01,



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this Manual prevails. If a revision of an SOP newer than those in Table 1.01 conflicts with this Manual, that SOP prevails.

1.05 Organization and Use of this Manual

This Manual serves as primary documentation of the ATS Quality Assurance System as applied to work covering testing of nuclear safety related equipment. The approach, responsibilities, and general requirements defined in this Manual are designed to ensure that ATS products and services conform to all necessary requirements (whether or not explicitly specified in contract documents).

The organization of this Manual is detailed as follows to assist in its effective use.

Authority of this Manual is defined in Chapter 0.

This chapter (1) is included to provide background information to give the reader a basis for, and context of, ATS’ quality system for testing of nuclear safety related equipment as described in this Manual.

A concise statement of quality policy promoted by ATS management, and endorsed by ATS employees, is presented in Chapter 2.

The organization of ATS management is described in Chapter 3 with particular emphasis on those organizational features that concern management of quality assurance within the scope of this Manual.

Chapter 4 contains descriptions of all relevant quality system elements. Each section of Chapter 4 includes subsections of “Scope” (§4.XX.00) and, if applicable, “Purpose” (§4.XX.01). Each “Scope” subsection addresses only the applicability3 of its section. The “Purpose” subsections are included only as an aid for understanding context; they contain no enforceable provisions.

Chapter 5 is a list of significant references used in the preparation of this Manual or cited herein. Each reference is preceded in boldface by an abbreviated title. These abbreviated titles are used throughout this Manual for citations.

Refer to the most recent revision of the separate document, ATS QAS-Glossary, for concise meanings of quality assurance and metrology related terms used herein.

3 Since this Manual is focused on work covering testing of nuclear safety related equipment,

some sections are not necessary herein and therefore only a brief description of why the section is not applicable is included under the applicable “scope” subsection.



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2 QUALITY POLICY

ATS management and employees are committed to the following Quality Policy:

1. Hold public health and safety paramount.

2. Strive to meet and exceed the expectations and needs of customers regarding quality and value.

3. Retain and promote the traditional quality of craftsmanship.

4. Whenever feasible, understand the end use of products and fulfill all reasonable requirements, whether specified or not.



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3 ORGANIZATIONAL STRUCTURE

3.00 Scope & Purpose

Only significant features of the ATS organizational structure which are germane to the Quality System and which are not business sensitive (such as financial features) are described here.

Except as described in this chapter, management reserves the right to establish chain of command and to assign tasks to its employees, as they deem appropriate.

The purpose of defining ATS’ organizational structure is to provide a clear and concise chain of command and to unambiguously define the duties, authorities, and responsibilities of applicable individuals involved in ATS management and the management of individual projects.

3.01 Legal Structure

Assurance Technical Services Inc. (ATS) is a closely held, for-profit corporation organized under Chapter 1701 of the Ohio Revised Code (ORC). It was incorporated on 06 Feb 1986.

ATS is licensed to provide professional engineering services pursuant to ORC 4733.

ATS conducts business on a fiscal year beginning on 01 February.

3.02 Internal Organization

ATS is functionally organized into five general areas of responsibility: Administration, Quality, Production, Facilities, and Marketing. Of these, Quality and Production are germane to this Manual. Figure 3.01 depicts the functional relationship of positions under these two areas of responsibility. The duties, responsibilities, and authorities associated with these positions are described in the sections that follow.

Note that Quality and Production are organized on a project basis. That is, project management positions (§3.06 - §3.08) are specifically assigned for each project. Also note that the Quality Assurance Manager and the Project Quality Manager may be, and often are, the same individual. Likewise, the Responsible Engineer and the Project Technical Manager usually are the same individual.



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Figure 3.01: Organization Chart

3.03 President

The President shall be a Registered Professional Engineer in the state of Ohio and shall be on record with the Ohio Professional Engineers and Surveyors Board as being in responsible charge of engineering work product of ATS. As such, he is responsible for ATS’ compliance with engineering licensure laws.

The President exercises all of the powers and bears all of the responsibilities normally associated with that position except as modified by the powers and responsibilities of a Responsible Engineer (§3.07).

The President is responsible for ensuring that the quality system is established, implemented, maintained, reported on, and improved. The President may delegate any part of any of these responsibilities to any qualified individual. Within this delegation authority, the President is responsible for appointing the Quality Assurance Manager (§3.04).

The President is also responsible for the technical competence of ATS work and may delegate this responsibility as necessary. Within this delegation authority, the President is responsible for appointing a Project Technical Manager (§3.06) or a Project Responsible Engineer (§3.07) to each project. Until such time that the President assigns a Project Technical Manager or a Project Responsible Engineer to a particular project, the President serves as the Project Responsible Engineer on that project.

If a Project Technical Manager that is not a Project Responsible Engineer is assigned to a project, then the President serves as Project Responsible Engineer on that project.

PRESIDENT

QUALITY ASSURANCE

MANAGER

PROJECT QUALITY

MANAGER

PROJECT STAFF

PROJECT TECHNICAL

MANAGER

RESPONSIBLE ENGINEER

CUSTOMER

COGNIZANT

ENGINEER



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3.04 Quality Assurance Manager

The Quality Assurance Manager is appointed by the President. The President may not serve as the Quality Assurance Manager.

The primary role of the Quality Assurance Manager is to ensure that all work and products of ATS meet all applicable statutory, regulatory, and contractual requirements regarding quality and documentation.

To this end, the Quality Assurance Manager is subordinate only to the President (§3.04), to whom he has free access. The Quality Assurance Manager has the freedom from conflicting pressures (e.g. production goals), exercises the authority, and assumes the responsibility to (i) identify quality problems, (ii) provide solutions to quality problems, (iii) verify implementation and validate effectiveness of solutions, and (iv) hold work pending proper disposition of a nonconformance, deficiency, or other unacceptable quality condition.

The Quality Assurance Manager is responsible for the following activities:

01. The Quality Assurance Manager is responsible for management of QA activities and records on the corporate (as opposed to project) level.

02. The Quality Assurance Manager conducts surveillances, coordinates internal audits, hosts & responds to external audits, and directs implementation of corrective & preventive actions identified by audit or otherwise. He determines any useful improvements to the quality system and, if necessary, causes this Manual and/or other applicable quality system documents to be revised or created accordingly.

03. The Quality Assurance Manager reviews the quality and documentation requirements of each order accepted by ATS and appoints a Project Quality Manager (§3.08) thereto. The Quality Assurance Manager supervises and/or supplements the appointee’s activities to verify that the appointee is competently completing his duties. Until such time that the Quality Assurance Manager assigns a Project Quality Manager to a particular project, the Quality Assurance Manager serves as the Project Quality Manager on that project.

04. The Quality Assurance Manager verifies and documents compliance with the requirements of 10CFR21.

05. The Quality Assurance Manager conducts a documented annual review to access the adequacy and effective implementation of the Quality Management System (QMS). At a minimum, the following topics are reviewed and presented to the President for his approval.

a. The output (plan) from previous QMS reviews.

b. Audits, including Internal & Customer Audits.

c. Corrective & Preventive Actions.

d. Deviations.

e. 10CFR21 Compliance.

f. Employee Training.

g. Changes that could affect the Quality System.

h. An assessment of the Quality System’s effectiveness.

i. A plan for improvements to the Quality System.



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3.05 Lead Auditors

Qualified Lead Auditors perform internal audits of ATS per §4.20 and audits of ATS suppliers per §4.22. Lead Auditors report to the President and the Quality Assurance Manager. Lead Auditors may be either employees of ATS or outside contractors.

Lead Auditors are qualified to objective criteria that demonstrate knowledge and experience in auditing organizations to the requirements of 10CFR50 Appendix B or ASME NQA1. Lead auditors are not used to audit their own work or in circumstances that could otherwise present a significant conflict of interest.

3.06 Project Technical Managers

Every order accepted by ATS has a Project Technical Manager. (Note that, depending on his qualifications, the Project Technical Manager may also be a Project Responsible Engineer per §3.07).

The Project Technical Manager for each project is appointed by the President. The President may appoint himself to this position. When a Project Technical Manager has not been explicitly appointed for a particular project, the President automatically serves in this capacity.

Within the scope of this Manual, the positions of Project Technical Manager and Project Quality Manager are not filled by the same individual.

A Project Technical Manager is subordinate to the President. Within the limitations of his authority, he bears responsibility for the technical content and quality conformance of product delivered under his management.

3.07 Responsible Engineers

Responsible Engineers are Registered Professional Engineers to whom the President has delegated the requisite authority and who have accepted the responsibility to direct engineering activities performed by ATS. The President serves, by default, as the Responsible Engineer on any scope of engineering work performed by ATS that has not been delegated to another Responsible Engineer.

Every order accepted by ATS that is subject to the scope of this Manual has a Project Responsible Engineer. When a Project Technical Manager is a Responsible Engineer, he is also the Project Responsible Engineer for the project to which he is assigned. When a Project Technical Manager is not a Responsible Engineer, a Responsible Engineer in the chain of command to the President serves as the Project Responsible Engineer lege artis on the applicable project.

A Project Responsible Engineer exercises ultimate authority over, and bears ultimate responsibility for, the impact on public health and safety of the product delivered under his management.

The Project Responsible Engineer applies his seal to each ATS Certificate of Conformance, or other applicable document, issued for projects under his supervision.



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3.08 Project Quality Managers

Every order accepted by ATS has a Project Quality Manager.

The Project Quality Manager for each project is appointed by the Quality Assurance Manager. The Quality Assurance Manager may appoint himself to this position. When a Project Quality Manager has not been explicitly appointed for a particular project, the Quality Assurance Manager automatically serves in this capacity.

Within the scope of this Manual, the positions of Project Technical Manager and Project Quality Manager are not filled by the same individual.

A Project Quality Manager is subordinate to the Quality Assurance Manager and to the President. Within the limitations of his authority, he is responsible for verifying and documenting the fulfillment of all applicable quality requirements on the project (as opposed to corporate) level.

If, due to the limitation of his authority, the Project Quality Manager cannot resolve a quality assurance related issue, he documents the discrepancy and reviews the issue and its documentation with the Quality Assurance Manager.

3.09 All ATS Personnel

Each ATS employee is responsible for the systematic implementation and improvement of the ATS quality system. Accordingly, it is the duty of each employee to understand and apply, in good faith, those elements of the quality system that apply to his work.

Furthermore, when the detailed implementation of quality system elements appears not to support the Quality Policy, an employee notifies his supervisor so that the issue can be clarified or the Quality System can be appropriately improved.

Personnel assigned to a particular project are subordinate to both the Project Quality Manager and the Project Technical Manager for that project.

3.10 Customer Cognizant Engineers

Every Special QA Grade project, and every Basic Grade project when so ordered by the Project Responsible Engineer, has at least one Customer Cognizant Engineer. A Customer Cognizant Engineer is an individual appointed by the Customer to exercise engineering authority on behalf of the Customer. His authority is exercised solely through liaison with the Responsible Engineer as shown in Figure 3.01 on page 17.

At least one individual must be appointed as a Customer Cognizant Engineer by the Customer in writing on its Purchase Order (or Purchase Order Revision or Change Order) before ATS can commence with work on a project.

Any subsequent appointments or revocations of appointments of Customer Cognizant Engineers must be made through a Purchase Order Revision or Change Order or otherwise in writing by an authorized individual within the Customer organization. Authorized individuals include only (i) those that have already been appointed as Customer Cognizant Engineers (per §3.10.13), (ii) someone identified on the Customer’s Purchase Order as the principal engineering or technical manager, or (iii) if the Customer is a licensed engineering



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firm, a licensed Professional Engineer identified in public records as being in responsible charge of the firm’s engineering product.

If the Customer has any internal controls that limit the Cognizant Engineer’s authority to act unilaterally, he is expected to abide by those limitations. ATS accepts no responsibility for overruling a Cognizant Engineer in the event that he violates Customer policy4.

Note that Cognizant Engineers are not necessarily employees of the Customer. They may be contractors, employees of the Customer’s customer, or others. However, in order to avoid conflicts of interest, a Customer Cognizant Engineer may not be an employee of ATS.

Note also that a Cognizant Engineer typically does not need to be a Registered Professional Engineer because he typically performs his work under a lawful industrial exemption. The qualifications of Customer Cognizant Engineers are solely the Customer’s responsibility.

Unless specifically excluded by the Customer in writing, a Cognizant Engineer has the following authorities and responsibilities:

01. Coordinate schedule of work with ATS.

02. Interpret or determine (as applicable) specifications, critical characteristics, and acceptance criteria on Customer’s behalf.

03. Identify, document, resolve, and approve (as applicable) Deviations to technical requirements.

04. Witness activities performed by ATS (e.g. testing) for Customer.

05. Set up, maintain, and operate (as applicable) Customer supplied equipment.

06. Coordinate shipments (including insurance) of customer supplied equipment, particularly the DUT.

07. Receive and acknowledge Notices of Anomaly and Deviation Records issued by ATS.

08. Receive and acknowledge notices that Notification or Hold Points have been reached by ATS.

09. Release hold points so that ATS may recommence its work.

10. Approve procedures, reports, and other technical documents, quality forms, or quality records prepared by ATS for the Customer.

11. Perform or supervise training of ATS personnel on Customer specific equipment and processes.

12. Abort a process (e.g. test) prematurely.

13. Appoint (deputize) other individuals to serve as Cognizant Engineer(s).

14. Document the above activities in the ATS maintained Logbook, or otherwise as applicable.

4 ATS can assume no responsibility to know or enforce the Customer’s policies regarding the

authority of its agents. ATS will recognize the orders of any Customer Cognizant Engineer as being valid orders of the Customer unless specific written instructions limiting his authority have been received from the authority responsible for his appointment. ATS presumes that Customer Cognizant Engineers are working within their authority.



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4 QUALITY SYSTEM ELEMENTS

4.01 Contract Review

4.01.00 Scope

Contract Review is the process by which quality requirements for each project are determined and applies to any order being considered for acceptance by ATS.

Negotiation of contracts is outside the scope of this Manual. Some of the activities in this section may be completed as part of the negotiation process before a Purchase Order is received. The intent of this section is to ensure that all necessary activities are completed before an order is accepted and work begins.

4.01.01 Purpose

The purpose of Contract Review (and of controlling the process) is to:

a. ensure that ATS and the customer have a clear, common understanding of what is required for each order,

b. determine the applicability of this Manual,

c. ensure that the customer’s purchasing documentation is acceptable,

d. verify that ATS has the resources to meet the order requirements, and

e. ensure that ATS initiates all actions required to meet all applicable quality, statutory, and contractual requirements.

4.01.02 Purchase Orders

Upon receipt of a Purchase Order5, the Quality Assurance Manager shall identify whether that order is subject to the scope of this Manual on the basis of the order’s requirements. For any such identified order, he is responsible for performance and documentation of a contract review.

Any order that is deemed to be subject to this Manual must meet the following minimum requirements prior to commencement of work thereunder:

01. The order must be in writing and contain a distinct identification (typically a PO number).

02. The order must identify individual(s) with authority to interpret technical requirements and make technical decisions on behalf of the Customer (typically a Cognizant Engineer).

03. The order must not include any terms or language that may create incentives to influence test results in a manner contrary to the interests of Public Health and Safety.

5 Upon receipt of a verbal order that may be subject to Basic or Special quality grade, a

written order will be required before proceeding with Contract Review.



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4.01.03 Change Orders

For any Change Orders issued by the customer on a project subject to this Manual, a contract review is performed subject to, as applicable, the same process, approvals and notifications as the original Purchase Order.

4.02 Project Quality Planning

4.02.00 Scope

Project Quality Planning applies to Project Quality Plans developed, revised, and implemented specifically for an individual order.

Project Quality Plans are required on all orders subject to the scope of this Manual.

4.02.01 Purpose

The purpose of Project Quality Planning (and of controlling the process) is to ensure that all applicable quality, statutory, and contractual requirements of a project are fulfilled.

4.02.02 Determination of Requirements and Implementation

The Quality Assurance Manager is responsible for maintaining a form for the preparation of Project Quality Plans.

The Project Quality Manager is responsible for determining the quality requirements applicable to his project, completing and maintaining a Project Quality Plan, and directing the implementation thereof.

4.03 Design Control

4.03.00 Scope

Design Control does not apply within the scope of this Manual because ATS does not presently seek to be qualified to provide nuclear safety related design services or to manufacture nuclear safety related equipment.

4.04 Design Documents

4.04.00 Scope

Design Documents applies to any documents used to present design process or results.

Within the scope of this Manual, design documents does not apply because ATS does not presently seek to be qualified to provide nuclear safety related design services or to manufacture nuclear safety related equipment.

4.05 Controlled Documents

4.05.00 Scope

Controlled Documents applies to any significant document, subject to revision, to which distribution needs to be controlled. Controlled Documents may or may not be produced by ATS.



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4.05.01 Purpose

The purpose of Controlled Documents (and of specifying the process) is to:

a. ensure that only the appropriate approved version of a controlled document (generally the latest revision) subject to revision is used, and

b. provide a means of tracking dissemination of proprietary and sensitive documents.

4.05.02 Identification of Controlled Documents

The Quality Assurance Manager is responsible for maintaining guidelines for identification of Controlled Documents and for identifying Controlled Documents that apply to multiple projects (e.g. this Manual).

4.05.03 Drafts

For documents authored by ATS, draft copies are clearly marked with the word “DRAFT” on every page and are identified as the next sequential revision number. (New documents are Revision 0; a draft change to Revision n would be Revision n+1.) Copies of documents marked “DRAFT” are not used for project work.

The Quality Assurance Manager verifies conformance with this requirement.

4.05.04 Revisions

For documents authored by ATS, the Quality Assurance Manager maintains a system by which documents are tracked that assures proper approvals and availability for distribution of each revision thereto.

4.05.05 Distribution of Controlled Documents

The Quality Assurance Manager is responsible for implementing, documenting, and maintaining a system of distribution of Controlled Documents that assures that all applicable personnel are using the proper approved version of each applicable document.

4.05.06 Release from Control

If and when there is no longer a need to maintain control of a particular document, said document may be released from document control according to a documented process prescribed by the Quality Assurance Manager.

4.06 Logbooks

4.06.00 Scope

Logbooks applies to bound contemporaneous record books typically maintained by Project Technical Managers.

4.06.01 Purpose

The purpose for maintaining Logbooks is to ensure that all aspects of a project are recorded accurately. On major projects several different employees may perform activities required by the project and record their activities in the project Logbook.



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The purpose of controlling the use of Logbooks is to ensure that all required data is recorded in a complete, consistent, and traceable manner.

4.06.02 Application

The Project Technical Manager maintains a Project Logbook of notes, calculations, and measurements pertinent to the technical aspects of the subject project per guidelines maintained by the Quality Assurance Manager.

Except during periods of project inactivity, the Project Quality Manager periodically reviews the Logbook to assure that it is being contemporaneously maintained.

4.06.03 Disposition

Upon completion of a project, the original of the Project Logbook remains in ATS custody and is treated as a Quality Assurance Record per §4.19.

4.07 Procurement Control

4.07.00 Scope

Procurement Control applies generally to any materials and services ATS obtains from external suppliers to conduct its business.

Within the scope of this Manual, procurement control (to nuclear safety related standards as detailed below) applies only to the procurement of:

a. Calibration services,

b. Sub-contractors performing nuclear safety related testing (e.g. radiation aging or seismic testing),

c. Shipping of DUT, and

d. Data acquisition software (see also §4.14.04).

4.07.01 Purpose

The purpose of Procurement (purchasing) Control (and of specifying the process) is to ensure that the material and services ATS orders are provided by ATS’ suppliers as specified. By ensuring that ATS’ suppliers can meet purchase order and quality requirements, ATS is capable of ensuring that ATS can meet its customer’s requirements.

4.07.02 General

The Quality Assurance Manager is responsible for maintaining an Approved Suppliers List (ASL) containing the names and approved scopes of supply for organizations qualified under §4.07.04 through §4.07.06 herein. The Project Quality Manager is responsible for verifying that applicable suppliers are on the ASL for the products or services being procured.

4.07.03 Purchase Orders and Change Orders

All orders by ATS of products or services subject to this Manual are documented as a Purchase Order. Revisions to ATS Purchase Orders are made incrementally as Change



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Orders. Applicable orders are placed only with suppliers that have been qualified per §4.07.04 through §4.07.06, or that are to perform their work under direct ATS quality supervision per §4.07.07.

The Project Responsible Engineer is responsible for confirming that all necessary technical requirements are specified in the applicable Purchase Order.

The Quality Assurance Manager is responsible for confirming that the order invokes all necessary applicable quality requirements and verifying that these requirements are met.

The Project Responsible Engineer is responsible for verifying that Purchase Orders contain no terms or language that may create incentives to influence test results in a manner contrary to the interests of Public Health and Safety.

4.07.04 Qualification of Supplier by Exemption

The Quality Assurance Manager is responsible for verifying Supplier Qualification by Exemption. The following suppliers may be considered qualified without an audit or evaluation:

01. The Customer for any product unless specifically prohibited by the Customer.

02. NIST for calibrations.

03. Other recognized national standards for calibration (e.g. Satellite GPS for time).

04. Suppliers specifically approved in writing by an Authorized Customer Representative for any approved product or service

4.07.05 Qualification of Supplier by Audit

The Quality Assurance Manager is responsible for Qualification of Suppliers by Audit in conformance with the following requirements:

01. A satisfactory audit of the supplier has been performed per §4.22 within either:

a. 36 months if the Supplier has been approved via at least the last two consecutive ATS audits, or

b. 12 months otherwise.

02. The Supplier’s qualification covers the product to be procured.

03. The Supplier is not pending approval of Corrective Action that applies to the product to be procured.

04. The Customer has the option to inspect the applicable Audit Report and, if so inclined, disapprove the supplier, provided notice is given in writing and includes the reason for disapproval.

4.07.06 Prequalification of Commercial Grade Suppliers by Evaluation

The Quality Assurance Manager is responsible for Prequalification of Suppliers that may be subsequently used to provide commercial grade services or products that will be commercially dedicated based on prequalification per §4.08.04.



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Prequalification is based on either of the following processes detailed in SOP 4.07-01.

01. Under certain conditions, Calibration suppliers (this includes suppliers of calibrated material measures, which, in turn, includes suppliers of certified reference materials) may be prequalified based on a third party accreditation.

02. Other suppliers may be prequalified for a specified scope of work by conducting a Commercial Grade Survey.

4.07.07 Performance by Supplier under ATS Quality Management

The Quality Assurance Manager is responsible for verifying and documenting supplier conformance with the ATS quality system, according to a Customer approved plan.

4.08 Commercial Dedication

4.08.00 Scope

Within ATS’ system, Commercial Dedication applies to the process of elevating a service or product from the Exempt or Basic quality grade to Special.

4.08.01 Purpose

The purpose of controlling Commercial Dedication is to assure that items or services provided by commercial suppliers for use in a Special Grade application (e.g. Nuclear Safety Related) meet all necessary technical, regulatory, quality, and documentation requirements.

4.08.02 Recognized Processes

ATS recognizes the four general processes for Commercial Dedication described in EPRI NP-5652 with modifications and limitations as described below and in the following subsections.

According to NRC guidance and consistent with ORC 4733, certain activities associated with Commercial Dedication fall within the practice of Engineering. These include development of specifications, determination of Critical Characteristics, determination of test and inspection requirements, and evaluation of test and inspection results. Hence, unless specified by an outside source, any such development, determination, or evaluation that originates from ATS must be made under the direction of, and signed by, a Responsible Engineer (§3.07).

4.08.03 Dedication based on Special Tests or Inspections

Method 1 of EPRI NP-5652 is Special Tests and Inspections.

ATS implements this method only if the specific process is described in a Commercial Dedication Instruction (CDI) that is controlled per §4.05 and has been approved in writing by an ATS Responsible Engineer (§3.07), the ATS Quality Manager (§3.04), and an authorized Customer representative (§4.01.02.02).

4.08.04 Dedication based on Prequalification

Method 2 of EPRI NP-5652 is Commercial Grade Survey of Supplier.



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ATS implements this method by prequalifying its commercial grade suppliers per §4.07.06. Written instructions with each Special grade order placed with a prequalified supplier (§4.07.03) must include written transmittal of Critical Characteristics. Receipt inspection from each such order must include verification that documentation from the supplier demonstrates that all Critical Characteristics have been met.

ATS recognizes that, under certain circumstances documented in SOP 4.07.01, accreditation through the International Laboratory Accreditation Cooperation Mutual Recognition Arrangement (ILAC-MRA) may be used in lieu of a Commercial Grade Survey.

4.08.05 Dedication based on Source Verification

Method 3 of EPRI NP-5652 is Source Verification.

ATS implements this method through quality supervision of its supplier per §4.07.07.

4.08.06 Dedication based on Historical Performance

Method 4 of EPRI NP-5652 is Acceptable Supplier / Item Performance Record.

ATS implements this method only to the extent that its justification is described in a Controlled Document (§4.05) that has been approved in writing by an ATS Responsible Engineer (§3.07), the ATS Quality Manager (§3.04), and an authorized Customer representative (§4.01.02.02).

4.09 Control of Customer Supplied Product

4.09.00 Scope

Control of Customer Supplied Product applies, within the scope of this Manual, only to test specimens provided for testing by a Customer.

4.09.01 Purpose

The purpose of controlling customer supplied product is to:

a. provide confidence to the customer that the specimens they supply are used as intended,

b. ensure that any loss or (non test-related) damage is identified and reported, and

c. ensure that the specimens are handled in a manner to minimize the potential for loss or (non test-related) damage while the product is in ATS custody.

4.09.02 Raw Materials and Components does not apply

4.09.03 Work in Process does not apply

4.09.04 Devices Under Test (DUT)

The Project Quality Manager is responsible for tracking and documenting chain of custody of each DUT in conformance with the following requirements:

01. Each DUT is inspected upon receipt and its condition and identity are verified.



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02. Each DUT is clearly labeled or segregated from other devices as necessary to prevent confusion.

03. Efforts are taken to protect each DUT from theft or damage, commensurate with its nature and value.

04. Any loss or damage to a DUT is promptly reported to an Authorized Customer Representative and consequent corrections will be planned.

05. Each DUT is subjected to the intended tests.

06. As applicable, each DUT is returned to the Customer in the condition resulting from its last test.

07. ATS ships the DUT per customer approved method.

4.09.05 Tools and Instruments

The Project Quality Manager is responsible for tracking any tools or instruments supplied by the Customer for work on its project as required to assure that they are stored, used, and returned as intended. He also is responsible for assuring that all ATS personnel using the Customer supplied tools and instruments have received any necessary training and for assuring that any Customer supplied calibration certification is complete, proper, and properly recorded.

The Project Technical Manager is responsible for assuring that Customer supplied tools and instruments are suitable for their intended purpose, that technically complete training is given to the necessary personnel, and that the tools and instruments are used properly.

4.10 Inventory Control

4.10.00 Scope

Inventory Control applies to the control of raw materials, work in progress, and finished product, not supplied by the customer, in the custody of ATS.

Within the scope of this Manual, inventory control does not apply because ATS does not presently seek to be qualified to manufacture nuclear safety related equipment.

4.11 Process Control

4.11.00 Scope

Process Control applies to any manufacturing process performed by, or under the management of, ATS.

Within the scope of this Manual, Process Control (including Control of Special Processes) does not apply because ATS does not presently seek to be qualified to manufacture nuclear safety related equipment. The test process, which is in the scope of this manual, is controlled by §4.13



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4.12 Inspection Control

4.12.00 Scope

Inspection Control applies to inspections performed by, or under the management of, ATS. Inspections of a customer’s device, process, or system performed as a contract deliverable are considered tests and are controlled under §4.13.

Within the scope of this Manual, inspection control applies to visual inspection of the DUT or other customer supplied items.

4.12.01 Purpose

The purpose for controlling inspections is to ensure that inspections are thorough and properly documented.

4.12.02 General

The Quality Assurance Manager is responsible for developing and maintaining inspection procedures.

The Project Quality Manager is responsible for performing necessary inspections.

4.13 Test Control

4.13.00 Scope

Test Control applies to tests performed by, or under the management of, ATS as a contract deliverable. Test Control applies to orders subject to the scope of this Manual.

4.13.01 Purpose

The purpose of controlling tests is to ensure that the tests ATS performs for its customers are conducted in a manner that meets all applicable quality, statutory, and contractual requirements. Controlling a test includes planning the test sequence, performing the test in accordance with the plan, recording all test results and anomalies accurately, and reporting the test and its results accurately.

4.13.02 General

The Project Responsible Engineer is responsible for conduct and control of all tests performed as part of his project(s).

The Project Quality Manager is responsible for verifying conformance with all applicable quality requirements and for verifying complete and proper documentation of activities and results.

All projects subject to this Manual have a governing Test Plan and/or a Test Procedure subject to Document Control per §4.05.

4.13.03 Anomalies

The Project Responsible Engineer and the Project Quality Manager are responsible for identifying, mitigating, documenting, and reporting Anomalies that are observed during testing according to an approved and documented process.



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4.14 Metrology

4.14.00 Scope

Metrology applies to all measurements and the instruments used to perform those measurements by, or under the management of, ATS.

4.14.01 Purpose

The purpose of controlling metrology is to:

a. meet all applicable statutory and contractual requirements for traceability of measurements,

b. ensure that all measurements made by ATS are as accurate as stated, and

c. ensure that all instruments calibrated by ATS are as accurate as stated.

4.14.02 Measurement Standards

The President is responsible for determining the requirements for, procuring, and maintaining in-house Measurement Standards.

The Quality Assurance Manager is responsible for procuring calibrations, and maintaining Calibration Records of, in-house Measurement Standards. Such records enable an auditable and traceable documentation trail from recognized national standards to calibrations and measurements performed by ATS as deliverables under projects subject to this Manual.

4.14.03 Calibrations

The President is responsible for determining calibration guidelines, and for approving calibration procedures and forms.

The Quality Assurance Manager is responsible for organizing and uniquely identifying records of all applicable calibrations performed by ATS and treating these Calibration Records as Quality Records per §4.19.

The Project Responsible Engineer is responsible for the competent completion of all necessary calibrations on his project(s).

The Project Quality Manager is responsible for verifying that all necessary calibrations have been completed & documented, and that all applicable instruments are within their respective calibration durations, for any measurements that will be reported to the Customer on his project(s).

4.14.04 Instruments

The Project Responsible Engineer is responsible for determining the suitability of instruments to be used on his project. This includes validation of data acquisition systems including their embedded software.

The Project Quality Manager is responsible for verifying that instruments being used on his project are controlled as necessary to assure accurate, traceable, and properly documented measurements.



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4.14.05 Measurements

The President is responsible for implementing, documenting, and maintaining standards that assure that measurements are traceable, as accurate as required, properly recorded, and auditable.

The Project Technical Manager is responsible for assuring that all measurements made in fulfillment of his project conform with the applicable test plan or procedure.

The Project Quality Manager is responsible for assuring that all measurements made in fulfillment of his project conform with the applicable project Quality Plan.

4.15 Identification of Product Status

4.15.00 Scope

Identification of Product Status applies to the tracking of work progress. This section applies to all orders subject to the scope of this Manual.

4.15.01 Purpose

The purpose of controlling the identification of product status is to:

a. ensure that all products are subject to all necessary processes, inspections, hold and notification points and tests in the intended order, and

b. provide a reliable means to ascertain in-process product status.

4.15.02 Application

The Project Quality Manager is responsible for creating, revising, and contemporaneously maintaining project tracking form(s). These forms provide for dates and personnel identification upon completion of each significant point in fulfillment of the applicable order.

4.16 Control of Nonconforming Product

4.16.00 Scope

Control of Nonconforming Product applies to materials, parts, and components supplied by ATS.

Control of Nonconforming Product does not apply within the scope of this manual because ATS does not presently seek to be qualified to supply nuclear safety related materials, parts, or components.

In the context of test services, Anomalies6 and Deviations7, fulfill ATS’ responsibilities related to Nonconformances.

6 ATS’ treatment of Anomalies (§4.13.03) addresses its obligations regarding suspected or

known nonconformances in test specimens supplied by other organizations. 7 ATS’ treatment of Deviations (§4.29) addresses its obligations regarding changes to

procedures.



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4.17 Corrective and Preventive Action

4.17.00 Scope

Corrective and Preventive Action applies to the determination and implementation of corrective and preventive actions. Corrective Actions are Quality System improvements implemented in response to a Deviation, non-compliance, or a notice from a Customer of system defect. Preventive Actions are Quality System improvements implemented in response to a reported gap or defect in the system that did not (yet) cause a Deviation or non-compliance.

4.17.01 Purpose

The purpose of Corrective and Preventive Actions is to improve ATS products and systems. The purpose of corrective action is to provide a means of handling a known problem so that the problem will not occur again. The purpose of preventive action is to provide a means of preventing a problem from occurring that might occur if a change is not made.

4.17.02 Determination

The Quality Assurance Manager is responsible for documenting policies for determining circumstances that warrant opening an investigation into a Corrective or Preventive Action.

4.17.03 Investigation

The Quality Assurance Manager is responsible for directing and documenting an investigation into the need for and nature of Corrective and/or Preventive actions according to documented guidelines.

The President evaluates all corrective actions to determine whether 10CFR21 applies and, if applicable, processes the identified defect or noncompliance per section §4.28.

The President and the Quality Assurance Manager are responsible for determining whether a significant condition adverse to quality exists and directing a prioritized mitigation accordingly.

The Quality Assurance Manager is responsible for determining what changes to Quality System Documentation are appropriate. Note that system documentation must remain consistent with the system’s provenance described in §1.03 and the policy described in Chapter 2.

4.17.04 Corrective Action

The Quality Assurance Manager is responsible for directing the timely implementation of each Corrective Action, and when applicable, validating its results. If the Corrective Action was triggered by a finding or a notification from a Customer, or if it resulted from a defective product having been released to a Customer, the Corrective Action report is made available to the applicable Customer’s quality organization.



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4.17.05 Preventive Action

The Quality Assurance Manager is responsible for directing the timely implementation of each Preventive Action, and when applicable, validating its results.

4.18 Handling, Storage, and Shipping

4.18.00 Scope

Handling, Storage, and Shipping applies to the receipt, handling, preservation, storage, packaging, and delivery of tangible products to customers. This section does not apply to handling, storage, or shipping of a DUT which is covered in §4.09.04.

Within the scope of this Manual, Handling, Storage, and Shipping does not apply because ATS does not presently seek to be qualified to manufacture nuclear safety related equipment.

4.19 Quality Assurance Records

4.19.00 Scope

Quality Assurance Records applies to any record documenting quality assurance activities generated by, or under the management of, ATS.

4.19.01 Purpose

The purpose of managing Quality Assurance records is to:

a. ensure that any records documenting Quality Assurance activities at ATS are recorded, maintained, and stored in a manner that ensures that the information will be authentic and retrievable, and

b. ensure that the records can only be disposed of appropriately.

4.19.02 Identification

The Project Quality Manager is responsible for the identification and collection of Quality Assurance Records of project specific activities. The Quality Assurance Manager is responsible for the identification and collection of Quality Assurance Records of activities that are not specific to one project.

4.19.03 Data Records

The Quality Assurance Manager is responsible for documenting policies for recording data.

The Project Quality Manager is responsible for verifying conformance with the ATS policies for record keeping on his project(s)

4.19.04 Storage

The Quality Assurance Manager is responsible for documenting policies for storage and surveillance of Quality Records and for implementing said policies.



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Applicable quality records shall be stored as duplicates in two or more locations sufficiently remote from each other to minimize the chance of exposure to a simultaneous hazard.

Regularly updated digital copies of quality records may be credited as a qualifying duplicate provided the physical media is under the control of ATS (including any ATS management personnel) and located at least 1 km distant from ATS offices.

4.19.05 Disposition

The Quality Assurance Manager is responsible for documenting policies for determining circumstances under which Quality Records may be disposed.

The Quality Assurance Manager is responsible for the disposition of quality records when applicable.

4.20 Internal Audits

4.20.00 Scope

Internal Audits applies to audits of the ATS quality system performed under the direction of ATS.

4.20.01 Purpose

The purpose of Internal Audits is to periodically check whether the ATS quality system is working and is being followed by ATS personnel. The purpose of controlling Internal Audits is to assure that they are effective and that any identified Corrective or Preventive Actions are initiated.

4.20.02 Implementation

The Quality Assurance Manager is responsible for documenting policies for planning, conducting, and reporting on periodic Internal Audits and for implementing said policies. Any findings are addressed by a corrective action per §4.17.

Audits are performed in accordance with written plans and checklists by an individual qualified as a Lead Auditor per §3.05. The Lead Auditor must not have direct responsibility for performing the activities being audited or other conflict of interest.

4.21 External Audits

4.21.00 Scope

External Audits applies to any audit of the ATS quality system performed under the direction of an organization other than ATS.

4.21.01 Purpose

The purpose of external audits is to verify that the ATS Quality System meets specified requirements and is being followed by ATS personnel. External audits are conducted by either ATS customers or by independent auditing organizations for the purpose of qualifying ATS as a supplier of nuclear safety related testing services.



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4.21.02 Customer Audits

The Quality Assurance Manager is responsible for documenting policies for Customer Audits and for implementing said policies. Any findings are addressed by a corrective action per §4.17.

A Customer Audit is permitted only upon authorization by the President. Upon authorization, it is coordinated and hosted by the Quality Assurance Manager.

In no case is a visiting Customer auditor allowed access to records containing confidential information owned by a different organization unless authorized in writing by the organization that owns the information.

4.21.03 Independent Audits

An independent audit may be ordered as a means of validating the effectiveness of the ATS quality system and/or securing certification.

The Quality Assurance Manager is responsible for coordinating and hosting Independent Audits. Any findings are addressed by a corrective action per §4.17.

4.22 Supplier Audits

4.22.00 Scope

Supplier Audits applies to quality audits of ATS suppliers performed under the direction of ATS.

4.22.01 Purpose

The purpose of supplier audits is to verify that organizations supplying goods and services to ATS meet all applicable quality standards.

4.22.02 General

Each Supplier Audit is planned and executed by an individual qualified as a Lead Auditor per §3.05 and verified to have no conflict of interest with the Supplier. Audits are conducted to document objective evidence confirming the following elements for the subject scope of supply:

01. The supplier’s quality system documentation meets applicable requirements.

02. The supplier conforms with its documented quality assurance system.

03. The supplier is technically competent.

4.22.03 Planning

A copy of the Supplier’s Quality System Manual is procured and evaluated for conformance with applicable requirements (e.g. 10CFR50 Appendix B). Based on this evaluation, an Audit Plan and checklist are prepared and approved by a Lead Auditor and the Quality Assurance Manager prior to conducting each supplier Audit.



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4.22.04 Implementation

Audits are performed by, or under the direct supervision of, the same Lead Auditor who approved the Audit Plan and Checklist per the following requirements:

01. ATS audit team members accept no gifts from the Supplier or its personnel.

02. The audit is conducted in accordance with the Audit Plan and Checklist.

03. Findings of discrepancies are communicated to the Supplier then schedules and responsibilities for implementation of necessary Corrective Actions are agreed upon.

04. A Lead Auditor approved report is generated describing the results of the Audit, including, as attachments, the Audit Plan and completed checklist.

4.22.05 Follow-up

The Quality Assurance Manager is responsible for confirming that any Corrective Actions required due to findings of discrepancies are effectively implemented according to the agreed schedules.

4.23 Personnel Qualifications

4.23.00 Scope

Personnel Qualifications applies to personnel skill, aptitude, education, experience, and training as it affects quality.

4.23.01 Purpose

The purpose of defining how personnel are qualified is to:

a. meet any applicable statutory and contractual requirements for the documentation of personnel qualifications, and

b. ensure that work performed for and by ATS is done by qualified personnel.

4.23.02 Qualification Requirements

The Quality Assurance Manager is responsible for the following:

01. Ensure that all ATS personnel are trained for the work they perform.

02. Conduct regular training on quality system requirements and on 10CFR21 for all ATS personnel that will be working on projects subject to this Manual.

03. Maintain records of training for all ATS personnel.

4.24 Servicing

4.24.00 Scope

Servicing applies to any activity performed, or additional product delivered, as a supplement to a product that has been delivered to a customer.



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4.24.01 Purpose

The purpose of controlling servicing is to ensure that ATS customers continue to be satisfied with ATS products after receipt.

4.24.02 Application

The Project Quality Manager verifies that any servicing performed in association with a nuclear safety related test program subject to this Manual is in compliance with the requirements of 10CFR21 and 10CFR50 Appendix B.

4.25 Statistical Techniques

4.25.00 Scope

Statistical Techniques applies to any non-trivial mathematical or graphical technique employed to analyze data or control a process.

4.25.01 Purpose

The purpose of controlling the use of statistical techniques is to ensure that techniques are developed and used appropriately. This helps prevent the misuse and misinterpretation of data and information.

4.25.02 Application

The President is responsible for prescribing organization-wide norms and guidelines for the use of Statistical Techniques developed and applied by ATS.

The Project Responsible Engineer is responsible for determining which Statistical Techniques are applied and for their proper application. Original recorded data is preserved, thereby providing fully auditable and reproducible results.

4.26 Hold & Notification Points

4.26.00 Scope

Hold & Notification Points applies to any specified point in the process of completing a project where work is required to stop pending notification of the Customer, whether specified verbally or in writing.

4.26.01 Purpose

Hold and Notification points are typically specified by the customer. The purpose of Hold and Notification points is to give the customer an opportunity to inspect product at specified points in the process. The purpose of controlling the implementation of Hold and Notification points is to prevent missing one inadvertently and, thus, not meeting a customer requirement.

4.26.02 Application

The Quality Assurance Manager is responsible for documenting policies for implementing Hold and Notification Points. The Project Quality Manager is responsible for including all applicable Hold and Notification Points in the Project Status Form and verifying implementation.



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4.27 Intellectual Property Protection

4.27.00 Scope

Intellectual Property Protection applies to reasonable measures taken to assure that the intellectual property of ATS, its Customers, its suppliers, and its personnel is protected as applicable from improper disclosure or loss of legal privilege.

4.27.01 Purpose

The purpose of controlling intellectual property protection is to assure that reasonable processes are implemented to safeguard the intellectual property rights of ATS, as well as those of its customers, suppliers, employees, and other business associates.

4.27.02 Non-Disclosure Agreements

The President negotiates and executes Non-Disclosure Agreements when necessary with ATS’ customers, suppliers, employees, and agents.

ATS maintains three classes of Non-Disclosure Agreements depending on the nature of the other party:

01. Agreements with other organizations

Non-disclosure agreements are negotiated and executed with Customers, Suppliers, and other organizations with which ATS conducts business and with which, in the opinion of the President, ATS needs to freely interchange proprietary or confidential information.

Each such agreement is reciprocal, protecting the applicable intellectual property rights of both signatories.8

ATS maintains a Mutual Confidentiality and Non-Disclosure Agreement form for this purpose that may be used. Alternatively, an agreement supplied by the other party may be used provided:

a. it is reciprocal,

b. it recognizes that the controlled release of information made in good faith to protect public health and safety (e.g. per 10 CFR 219) cannot be prohibited,

c. the individual executing the agreement on behalf of the other organization is duly authorized to so bind his organization, and

d. the agreement is otherwise lawful.

8 Reciprocal, or “Mutual”, Non-Disclosure agreements are necessary for ATS to be able to

assure protection of the intellectual property rights of its other business associates from being unwittingly disclosed to a customer who, having imposed a unilateral Non-Disclosure Agreement, is not bound to protect intellectual property obtained from ATS.

9 Per 10 CFR 21.41, the NRC has unfettered access to applicable records; no warrant or subpoena is required or expected to be issued. Similarly, as a licensed Engineering organization, ATS must hold Public Health and Safety paramount (see §2.1), so information may be shared with applicable public authorities other than the NRC.



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02. Agreements with ATS associates

Non-disclosure agreements are negotiated and executed with employees, contractors, and other individuals associated with ATS that may, in the opinion of the President, become privy to intellectual property owned by ATS or any organization with which ATS has a Mutual Non-Disclosure Agreement.

ATS maintains an Associate Confidentiality and Non-Disclosure Agreement form for this purpose. Each such agreement provides assurance that those individuals exposed to privileged intellectual property while under ATS management are duly obligated to honor ATS’ organizational duty under §4.27.02.01.

03. Agreements with Agents of other organizations

From time to time, individuals acting on behalf of another organization must be, in the opinion of the President, granted access to ATS intellectual property, yet no Mutual Non-Disclosure Agreement is in place with his organization and the individual is not authorized to execute such an agreement per §4.27.02.01.c.10

ATS maintains an Agent Confidentiality and Non-Disclosure Agreement form for this purpose. Each such agreement provides assurance that the agent is duly obligated to protect the confidential intellectual property to which he may be exposed and to mutually bind ATS to protect any confidential information that may be divulged by the agent.

The Agent Agreement is designed and intended to subsequently be superseded by a Mutual Confidentiality and Non-Disclosure Agreement (per §4.27.02.01) with his organization.

4.28 Reporting of Defects and Noncompliance

4.28.00 Scope

Reporting of Defects and Noncompliance applies to any work subject to 10CFR21 or any other reasonably known statutory reporting requirements.

The requirements of 10CFR21 apply to work subject to this Manual. Pursuant to ORC 4733, these requirements apply regardless of the destination country of equipment being tested by ATS.

4.28.01 Purpose

The purpose of defining how to report defects and noncompliance is to ensure that public health and safety are safeguarded and that statutory reporting requirements are met.

10 A common example of a situation in which an individual must be granted access to ATS

controlled intellectual property is a QA auditor performing an audit of ATS’ quality system per §4.21 prior to execution of a Mutual Confidentiality and Non-Disclosure Agreement with the organization he represents.



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4.28.02 Application

The Quality Assurance Manager is responsible for performing and documenting regular training and evaluation of ATS personnel on the requirements of 10CFR21 and for meeting all applicable posting requirements of that regulation.

All ATS personnel working on projects subject to this Manual are responsible for noting any potential applicable instance of defect or noncompliance and promptly reporting same to management.

The President is responsible for evaluating the seriousness of each internal report of potential defect or noncompliance and making any necessary notifications to customers or applicable regulatory agencies (e.g. NRC).

4.29 Deviations

4.29.00 Scope

Deviations11 applies to departures from any quality or technical requirement of any applicable manual, procedure, or contract document, whether planned in advance or recognized after its occurrence.

4.29.01 Purpose

The purpose of defining how Deviations are managed and authorized is to ensure that all instances of Deviations are properly addressed.

Note that there is no objective to reduce or eliminate the occurrences of Deviations. Often, Deviations are pre-planned and pre-authorized as solutions to operational problems that arise during a project.

4.29.02 Application

The Quality Assurance Manager is responsible for implementing, maintaining, and documenting a system for managing Deviations. The system ensures that all instances of Deviations are properly documented and approved and that any indicated Corrective Actions are initiated per §4.17.

4.30 Software Control

4.30.00 Scope

Software Control applies to the control of computer software as it affects quality. Primarily, Software Control consists of Software Configuration Management as well as Software Verification and Validation.

Within the scope of this Manual, Software Control does not generally apply because ATS does not presently seek to be qualified to supply nuclear safety related software.

11 Note that a Deviation is not a Nonconformance as referred to in criterion XV of 10CFR50

Appendix B. Whereas Nonconformances (§4.16) relate to materials, parts, or components which do not conform to requirements, Deviations relate to departures from written instructions.



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However, real-time data collected during tests (e.g. temperatures, pressures, etc.) do serve a nuclear safety related purpose. Calibration of computer based data acquisition systems used by ATS is performed in an integrated system condition (software plus hardware) thereby validating the software. This issue is addressed in §4.14.04.



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5 REFERENCES

The applicable sections of the following references were reviewed during the preparation of this Manual. Each reference is preceded in boldface by an abbreviated title. These abbreviated titles are used throughout this Manual for citations.

Copies of all references are available in ATS offices, for use or review whenever necessary.

10CFR21, Reporting of Defects and Noncompliance, U.S. Government Printing Office, latest revision at: http://www.nrc.gov/reading-rm/doc-collections/cfr/part021/

10CFR50.49, Environmental Qualification of Electric Equipment Important to Safety for Nuclear Power Plants, U.S. Government Printing Office, latest revision at: http://www.nrc.gov/reading-rm/doc-collections/cfr/part050/part050-0049.html

10CFR50-App B, Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants, U.S. Government Printing Office, latest revision at: http://www.nrc.gov/reading-rm/doc-collections/cfr/part050/part050-appb.html

ASME NQA-1-1994, Quality Assurance Program Requirements for Nuclear Facility Applications, ©1994, The American Society of Mechanical Engineers.

EPRI NP-5652, Guideline for the Utilization of Commercial Grade Items in Nuclear Safety Related Applications, Jun 1988, Electric Power Research Institute

IEEE 323-1974, IEEE Standard for Qualifying Class 1E Equipment for Nuclear Power Generating Stations, ©1974, The Institute of Electrical and Electronics Engineers, Inc.

IEEE 323-1983, IEEE Standard for Qualifying Class 1E Equipment for Nuclear Power Generating Stations, ©1983, The Institute of Electrical and Electronics Engineers, Inc.

IEEE 344-1987, IEEE Recommended Practice for Seismic Qualification of Class IE Equipment for Nuclear Power Generating Stations, ©1987, The Institute of Electrical and Electronics Engineers, Inc.

ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories, 2005, International Organization for Standardization.

ISO 9001, Quality management systems – Requirements, 2008, International Organization for Standardization.

OAC 4733-35, Ohio Administrative Code, Chapter 4733, Part 35, Code of Ethics for Engineers and Surveyors, State of Ohio, latest revision at: http://codes.ohio.gov/oac/4733-35.

ORC 4733, Ohio Revised Code, Chapter 4733, Professional Engineers and Surveyors, State of Ohio, latest revision at: http://codes.ohio.gov/orc/4733.

http://www.nrc.gov/reading-rm/doc-collections/cfr/part021/

http://www.nrc.gov/reading-rm/doc-collections/cfr/part050/part050-0049.html

http://www.nrc.gov/reading-rm/doc-collections/cfr/part050/part050-appb.html

http://codes.ohio.gov/oac/4733-35

http://codes.ohio.gov/orc/4733